Share This Page
Suppliers and packagers for ACCRUFER
✉ Email this page to a colleague
ACCRUFER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Shield Tx | ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320 | NDA | Shield TX (UK) Ltd | 73059-001-10 | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC | 2021-07-01 |
| Shield Tx | ACCRUFER | ferric maltol | CAPSULE;ORAL | 212320 | NDA | Shield TX (UK) Ltd | 73059-001-60 | 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC | 2021-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ACCRUFER
Last updated: June 6, 2026
ACCRUFER (ferric maltol) supplier landscape: manufacturers, API sources, and key commercial partners
Executive summary: ACCRUFER (ferric maltol) is supplied by Shield Therapeutics for commercial distribution in the US market. The product is supported by a Ferric maltol (iron(III) maltolate) supply chain centered on ferric maltol manufacture and bulk/material control, with contracted manufacturing and packaging performed by specialized pharmaceutical CDMOs and internal/affiliated manufacturing sites used under commercial supply agreements.
Who supplies ACCRUFER in the US and what companies are involved?
Direct supplier / commercial distributor
- Shield Therapeutics is the branded-product commercial supplier for ACCRUFER in the US.
Manufacturing and packaging
- ACCRUFER is produced through pharmaceutical manufacturing networks that typically include:
- Bulk ferric maltol manufacture (chemical synthesis and solid-state processing)
- Drug product manufacturing (tablet blending, compression, coating)
- Packaging and release testing (bottling, labeling, quality control disposition)
- Contract manufacture and batch release are handled by licensed manufacturers/CDMOs operating under commercial supply agreements tied to finished-goods specifications.
Key business implication
- For licensing, procurement, or litigation diligence, the actionable mapping is:
- Brand owner and commercial supply entity (Shield Therapeutics for US distribution)
- Finished-goods manufacturer(s) for tablets
- API/ferric maltol bulk manufacturer(s) for supply continuity
What is the ACCRUFER API supply chain for ferric maltol?
Substance
- ACCRUFER’s active is ferric maltol (iron(III) maltolate).
Typical API chain structure
- Ferric maltol is generated by chemical synthesis routes producing iron(III) chelation complexes with maltol, followed by purification and solid-state control (particle size, polymorph/solid form behavior where relevant).
Procurement-relevant supplier nodes
- API manufacturer(s) supplying bulk ferric maltol under GMP with:
- Certificate of Analysis and specification alignment
- Defined polymorphic/particle-size ranges
- Stability data supporting shelf-life and re-test periods
- Drug product manufacturer(s) converting API to ACCRUFER tablets (excipient selection, tablet strength and dissolution performance).
Which CDMOs or contract manufacturers produce ACCRUFER tablets?
Answer in business terms
- ACCRUFER tablet manufacturing is performed by commercial GMP manufacturers/CDMOs contracted for:
- tablet formulation execution
- scale-up and process validation
- cGMP batch release testing (assay, dissolution, water content where applicable)
- packaging to US labeling requirements
What to check in diligence files
- Batch records and stability packs for:
- tablet strength consistency across lots
- dissolution method comparability
- coating and tablet uniformity controls
Litigation relevance
- For any competitor attempting a generic or authorized-supply strategy, drug product manufacturing sites and their process controls often determine manufacturing-IP risk more than excipient-level selection alone.
What is the Orange Book status of ACCRUFER and how does it affect supplier planning?
Regulatory filing structure
- ACCRUFER (ferric maltol) is an oral iron therapy drug product with an NDA that includes patent and exclusivity information.
Why this matters for “suppliers”
- While supplier lists reflect operational manufacturing, Orange Book status drives:
- whether manufacturers can legally supply (for generics, para-generic, or authorized alternatives)
- whether a supplier or competitor must pursue licensing
- risk of Paragraph IV-driven injunctions for abbreviated pathways
Actionable supplier planning
- If entering the supply chain as a partner to a competitor, you map:
- patent thickets to identify potential legal hold points
- formulation, method-of-use, and manufacturing-process patents tied to drug product performance and stability
(This section is framed at the operational level because the question is supplier-focused, not a full Orange Book patent-by-patent catalog.)
What patent estate issues affect suppliers of ACCRUFER or ferric maltol equivalents?
Key risk categories
- Composition/polymorph or solid-state control patents tied to ferric maltol
- Formulation patents covering tablet composition and/or performance targets
- Method-of-use patents tied to anemia or iron deficiency treatment regimens
- Manufacturing/process patents affecting synthesis or drug product preparation
Supplier impact
- Even where API supply is available, a finished-goods supplier may face:
- patent infringement risk tied to drug product formulation
- injunction risk that disrupts supply continuity
- licensing costs under settlement or authorization agreements
When do competitors gain generic or biosimilar entry risk for ferric maltol?
Entry drivers
- For non-biologics like ferric maltol, the key timing drivers are:
- NDA exclusivity end
- patent expiration / carve-outs
- any granted 80-day stays (if Paragraph IV is filed) and resulting settlements
Supplier consequence
- The nearer to exclusivity/patent cliff dates, the more supplier competition shifts from engineering and sourcing to:
- contract manufacturing readiness
- rapid QC validation and stability alignment
- legal readiness for launch
How does ACCRUFER’s supply chain differ from other oral iron products?
Commercial contrast
- ACCRUFER competes in the oral iron deficiency anemia space against other iron formulations (ferrous salts, ferric complexes, sucroses, and other iron polymaltose/ferric derivatives).
- Supply chain differences are mainly:
- API synthesis complexity (chelate-based vs salt-based)
- solid-state behavior and tablet performance controls
- dissolution and absorption performance targets used during formulation development
Supplier strategy
- Suppliers in iron products frequently diversify:
- API vendors
- milling/granulation packages
- tablet compression and coating lines
- QC testing frameworks to match dissolution and release specifications
ACCRUFER supplier mapping table (operational diligence view)
| Supply chain node | What it supplies | Typical responsible party type | What to confirm in diligence |
|---|---|---|---|
| Commercial supplier | Branded product distribution | Brand owner/commercial operations | US distribution entity, contracts, allocation rules |
| Finished drug product manufacturer | ACCRUFER tablets (bulk-to-finish) | NDA/contract manufacturer | Site(s), batch release, stability ownership |
| API/ferric maltol manufacturer | Ferric maltol bulk | API chemical manufacturer | solid form, specs, change control history |
| Packaging/QC | Bottling, labeling, release testing | Manufacturer-owned or CDMO packaging arm | QC release testing methods and acceptance criteria |
| Logistics | Cold-chain not typically needed for tablets | 3PL | warehousing, shelf-life, temperature excursions policies |
Key Takeaways
- Shield Therapeutics is the commercial supplier for ACCRUFER in the US.
- The operational supply chain splits into API ferric maltol manufacture, finished tablet manufacturing, and packaging/release testing, typically across licensed GMP sites and contracted partners.
- For supplier qualification, the critical diligence targets are site responsibility for batch release, ferric maltol solid-state/material specifications, and tablet performance controls that tie into patent and exclusivity-driven launch constraints.
FAQs
Who is the commercial owner/supplier of ACCRUFER?
ACCRUFER is supplied in the US commercially by Shield Therapeutics.
Is ACCRUFER manufactured by internal facilities or CDMOs?
ACCRUFER tablet manufacturing is handled by licensed GMP manufacturers, which can include internal and contract manufacturing networks under commercial supply agreements.
Where does ferric maltol (the ACCRUFER API) come from?
Ferric maltol is sourced from GMP-compliant ferric maltol API manufacturers that supply bulk material meeting specification for drug product conversion.
What supplier components are most constrained: API or finished tablets?
Both nodes can be constrained, but in practice, constraint often concentrates on API solid-state/specification control and the drug product site’s dissolution/performance validation.
How do patents and exclusivity affect who can supply ACCRUFER equivalents?
Patent and exclusivity status shape legal ability to supply finished-goods equivalents, not only the practical ability to source ingredients.
References (APA)
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA.
- FDA. Drugs@FDA: ACCRUFER (ferric maltol) NDA information. U.S. FDA.
- Company disclosures and product labeling for ACCRUFER (ferric maltol). Shield Therapeutics.
More… ↓
